Introduction/Background HPV clearance and resolution of HPV dependent cervical lesions become difficult in menopausal women. The aim of this sub-analysis was to evaluate the effect of a multi-ingredient Coriolus versicolor-based vaginal gel (Papilocare®) in repairing high-risk (HR) HPV-dependent low-grade cervical lesions in women over 40-years-old.

Methodology The Paloma study (NCT04002154) was a multicenter, randomized, open-label, parallel-group, watchful waiting approach-controlled clinical trial. Unvaccinated HPV positive women aged between 30–65 with cytology of ASCUS or LSIL and concordant colposcopy image were randomized into 3 groups: A) treatment with the Coriolus versicolor-based vaginal gel 1 cannula/day for 1 month + 1 cannula/alternate days for 5 months; B) treatment with the Coriolus versicolor-based vaginal gel 1 cannula/day for 3 months + 1 cannula/alternate days for 3 months; C) control group: watchful waiting approach. The Papilobs study (NCT04199260) was an observational, multicenter, prospective, one-cohort study. Vaccinated or unvaccinated HPV-positive women over 25-years-old with cytology of ASCUS or LSIL and concordant colposcopy were included. Patients were treated with the Coriolus versicolor-based vaginal gel 1 cannula/day for 21 days during the first month + 1 cannula/alternate days for 5 months. A sub-analysis involving patients from both studies, over 40-years-old with HR-HPV was performed.

Results 30 and 68 HR-HPV patients above 40-years-old were evaluated in the Paloma and Papilobs studies, respectively. In the Paloma trial, normal cytology and concordant colposcopy was observed in 90% vs 33% patients in A+B vs. control groups, respectively, (p=0.003, Fisher test). In the Papilobs study, normal cytology and concordant colposcopy was achieved in 73.5% of patients.

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Abstract #903 Figure 1

Low-grade cervical lesion normalization at 6 months in HR-HPV women > 40-years-old

Conclusion After a 6-month treatment, the Coriolus versicolor-based vaginal gel has shown clinically robust and statistically significant efficacy in repairing cervical HR-HPV lesions in women over 40-years-old vs watchful waiting approach. This efficacy was corroborated in the real-life study.

Disclosures .